510(k) K160159 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Active-X Total Knee System
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Sep 6, 2016 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160159
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.